Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ITREL(R) 3 SYSTEM |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | MEDTRONIC NEUROMODULATION 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432 |
PMA Number | P840001 |
Supplement Number | S050 |
Date Received | 01/29/2001 |
Decision Date | 07/26/2001 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ITREL(R) EZ(TM) MODEL 7434A PATIENT PROGRAMMER, TO BE USED WITH THE MODEL 7425 ITREL(R) 3 IMPLANTABLE PULSE GENERATOR, AND LABELING MODIFICATIONS RESULTING FROM THE INTRODUCTION OF THE NEW PATIENT PROGRAMMER. |
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